Medtronic Advances Research on Drug-Eluting Balloons for Coronary and Peripheral Artery DiseaseData from 1,500-Patient IN.PACTâ¢ Clinical
Program Presented at TCT;
First Patient Enrolled in European Study
on Deviceâs
Use in SFA Disease

September 28, 2010
-- Washington -- Advancing research
on drug-eluting balloons for the treatment of coronary and
peripheral
artery
disease, Medtronic, Inc. (NYSE:
MDT), today announced the latest results from the IN.PACT drug-eluting
balloon (DEB) clinical program presented last week at the Transcatheter
Cardiovascular Therapeutics (TCT) 2010 conference.

The company
also announced the start of a key clinical study of the IN.PACT
Admiral (DEB) for the treatment of superficial femoral artery
(SFA) disease.

During TCTâs Drug-Eluting Stent (DES) Summit session on âNext Generation DES, Bioabsorbable Stents, and Drug-Eluting Balloons,â interventional
cardiologist Bruno Scheller, M.D., professor of internal medicine
and cardiology at the University of Saarland in Homburg/Saar, Germany,
presented six-month final results of the investigator-initiated
IN.PACT CORO ISR study on coronary in-stent restenosis. Prof. Scheller
also presented an overview of the FreePac technology and interim
findings from the larger IN.PACT clinical program, which includes
studies of both coronary and peripheral applications of the IN.PACT
family of drug-eluting balloons.

âBased on a growing body of clinical data and while results of randomized trials are awaited, IN.PACT drug-eluting balloons show great promise for the treatment of both coronary and peripheral arterial disease,â Prof. Scheller said. âThe
best potential applications appear to be in atherosclerotic
leg vessels and for previously stented coronary arteries that
have restenosed. Drug-eluting balloons may very well become
the fourth therapeutic platform for cardiovascular interventions,
joining traditional balloon angioplasty, bare-metal stents
and drug-eluting stents.â

IN.PACT drug-eluting balloons feature a proprietary, hydrophilic coating called FreePac that frees and separates paclitaxel molecules, facilitating their absorption into the vessel wall to mitigate re-narrowing of the artery over time. The IN.PACT clinical program consists of studies on the treatment of de-novo coronary lesions and coronary in-stent restenosis, as well as below-the-knee (BTK) and superficial femoral artery (SFA) disease. A combination of company-sponsored and physician-initiated studies, it will enroll a total of approximately 1,500 patients.

As part of his TCT presentation, Prof. Scheller highlighted IN.PACT CORO ISR, a single-center, single-arm confirmatory study of the IN.PACT Falcon DEB for the treatment of coronary in-stent restenosis conducted in 23 consecutive patients with a total of 26 lesions. The primary endpoint was late lumen loss measured by angiographic follow-up at six months. In the study, in-stent late lumen loss with the IN.PACT Falcon DEB was just 0.07 mm at six months, indicating a minimal degree of tissue growth inside the stented segment of the treated vessel.

The newly-initiated IN.PACT SFA I trial is investigating the safety and efficacy of the IN.PACT Admiral paclitaxel-eluting percutaneous transluminal angioplasty (PTA) balloon catheter in the SFA compared to treatment with a standard PTA balloon. It will enroll 150 patients at up to 20 sites in Europe. The primary endpoint is clinically-driven target lesion revascularization (TLR, the need for repeat procedures) or restenosis (the re-clogging of an artery) at 12 months. Prof. Gunnar Tepe, M.D., chief of radiology at Klinikum Rosenheim in Germany, is the principal investigator. The first patient in the IN.PACT SFA I trial was treated earlier this month by Prof. Marianne Brodmann, M.D., and her team in the department of angiology at the University of Graz in Austria.

Medtronic is committed to advancing the treatment of cardiovascular disease through collaboration with leading clinicians, researchers and scientists worldwide.

About Medtronic
Medtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology â alleviating
pain, restoring health and extending life for millions of people
around the world.

Any forward-looking statements are subject
to risks and uncertainties such as those described in Medtronicâs
periodic reports on file with the Securities and Exchange Commission.
Actual results
may differ materially from anticipated results.